Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test

Journal of Pharmaceutical Innovation
A BugnoTerezinha de Jesus Andreoli Pinto

Abstract

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test. There was no significant difference between the ability of the culture media to allow detection of microbial contamination. However, the rapid sterility testing method allowed a more rapid detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.

References

Jul 1, 1990·Journal of Clinical Microbiology·T C ThorpeL B Reller
Oct 17, 1998·Journal of Clinical Microbiology·P BourbeauC Pierson
Jan 13, 1999·Diagnostic Microbiology and Infectious Disease·A P GibbB Chorel
Dec 1, 1999·Diagnostic Microbiology and Infectious Disease·N CornishJ A Washington
Aug 2, 2000·Pediatrics·K L McGowanS E Coffin
Apr 13, 2012·Diagnostic Microbiology and Infectious Disease·Eva-Lena EricsonVolkan Ozenci
May 25, 2012·TheScientificWorldJournal·Hervé MederSébastien Ribault
Oct 12, 2014·Journal of Laboratory Automation·Juan Peris-VicenteJosep Esteve-Romero
Sep 29, 2015·Brazilian Journal of Microbiology : [publication of the Brazilian Society for Microbiology]·Adriana BugnoTerezinha de Jesus Andreoli Pinto

❮ Previous
Next ❯

Citations

Jan 8, 2019·Experimental Biology and Medicine·Paula Hansen SussFelipe Francisco Tuon
Jul 22, 2018·SLAS Technology·C SurretteC M Puleo
Mar 6, 2021·Molecular Therapy. Methods & Clinical Development·Salvatore PasquaDanilo D'Apolito

❮ Previous
Next ❯

Methods Mentioned

BETA
membrane filtration

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Brazilian Journal of Microbiology : [publication of the Brazilian Society for Microbiology]
A BugnoTerezinha de Jesus Andreoli Pinto
Journal of Pharmaceutical Sciences
F Bowman
© 2022 Meta ULC. All rights reserved